TPP: For oral therapy of acute uncomplicated urinary tract infection (cystitis)

Target product profiles for oral therapy of urinary tract infections

1 January 2020
Indication

Minimum/Acceptable: Treatment of acute uncomplicated community-acquired lower UTI in women (cystitis). Preferred/Optimal/Ideal: Treatment of acute uncomplicated community-acquired lower UTI (cystitis) in women with confirmed or increased risk for multidrug-resistant (MDR) Gram-negative (incl. ESBL-producing) pathogens, or in need of an alternative therapy to nitrofurantoin, fosfomycin or pivmecillinam.

Intended use
New oral antibacterial drugs without cross-resistance to existing classes and without selection pressure on existing classes are needed to provide an alternative to nitrofurantoin, fosfomycin trometamol and pivmecillinam. Such new drugs would require high urinary concentrations and activity, but not necessarily high blood concentrations.
Target population

Minimum/Acceptable:  Adolescents and adults (women) with suspected MDR Gram-negative pathogens. Preferred/Optimal/Ideal: Adolescents and adults (women) with suspected MDR Gram-negative pathogens.

Efficacy
Minimum/Acceptable: Non-inferior clinical activity to current therapies in acute infections with susceptible pathogens: ciprofloxacin, pivmecillinam and co-trimoxazole. Clinical trials should include elderly patients (> 65 years). Preferred/Optimal/Ideal: Non-inferior clinical activity to current therapies in acute infections with susceptible pathogens: ciprofloxacin, pivmecillinam and co-trimoxazole. Clinical trials should include elderly patients (> 65 years).
Safety
Minimum/Acceptable: Comparable to current therapies with β-lactams, no toxicity signals in preclinical reproduction toxicity studies. Preferred/Optimal/Ideal: Comparable to current therapies with β-lactams, no indication for toxicity signals in preclinical reproduction toxicity studies.
Product type
Drug
Status
Active
Safety

Formulation/presentation:: Minimum/Acceptable: Suggestion: tablets/capsules/sachet. Preferred/Optimal/Ideal: Suggestion: tablets/capsules/sachet. Dose regimen:: Minimum/Acceptable: 1–3x daily, treatment duration 1–5 days. Preferred/Optimal/Ideal: 1–2x daily, treatment duration 1–5 days. Route of administration:: Minimum/Acceptable: Oral. Preferred/Optimal/Ideal: Oral. Duration of treatment:: Minimum/Acceptable: 1-5 days. Preferred/Optimal/Ideal: 1-5 days. Stability and storage:: Minimum/Acceptable: Heat stable, 1-year shelf life in hot tropic/humid climate (simulated with 30°C and 65% relative humidity). Preferred/Optimal/Ideal: Heat stable, 3-year shelf life in hot tropic/ humid climate (simulated with 30°C and 65% relative humidity).

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